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Completed

NCT Number: NCT01944631

Iota-Carrageenan Nasal Spray in Common Cold

The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on cold symptoms. The effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1326.1.44001 Boehringer Ingelheim Investigational Site

Cardiff, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration
  • Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale
  • Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale
  • Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed.

Exclusion criteria

  • Known hypersensitivity or are allergic to any component of the test device
  • Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
  • Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
  • History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
  • Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics
  • Common cold or flu like symptoms for more than 48 hours.
  • Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines)
  • Current smoker (more than 10 cigarettes a day)

Treatment and study plan

PLACEBO

Device

Nasal spray saline

Iota-Carrageenan

Device

Nasal spray containing 1.20 g/l Iota-Carrageenan in saline

Primary outcomes

  1. Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)

    Time frame: Days 2, 3 and 4

    The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.

    Each common cold symptom was scored on a 4-point ordinal scale:

    • 0 = symptom not present
    • 1 = mild symptom (I can feel it but it has not disturbed or irritated me)
    • 2 = moderate symptom (symptom has disturbed and irritated me some of the time)
    • 3 = severe symptom (symptom has disturbed and irritated me most of the time)

    The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms).

Secondary outcomes

  1. Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)

    Time frame: Days 2, 3 and 4

    The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness).

    Each common cold symptom was scored on a 4-point ordinal scale:

    • 0 = symptom not present
    • 1 = mild symptom (I can feel it but it has not disturbed or irritated me)
    • 2 = moderate symptom (symptom has disturbed and irritated me some of the time)
    • 3 = severe symptom (symptom has disturbed and irritated me most of the time)

    The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms).

  2. Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)

    Time frame: Days 2, 3 and 4

    The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing).

    Each common cold symptom was scored on a 4-point ordinal scale:

    • 0 = symptom not present
    • 1 = mild symptom (I can feel it but it has not disturbed or irritated me)
    • 2 = moderate symptom (symptom has disturbed and irritated me some of the time)
    • 3 = severe symptom (symptom has disturbed and irritated me most of the time)

    The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms).

  3. Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)

    Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10

    The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.

    Each common cold symptom was scored on a 4-point ordinal scale:

    • 0 = symptom not present
    • 1 = mild symptom (I can feel it but it has not disturbed or irritated me)
    • 2 = moderate symptom (symptom has disturbed and irritated me some of the time)
    • 3 = severe symptom (symptom has disturbed and irritated me most of the time)

    The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms).

  4. Duration of the Cold

    Time frame: Baseline up to 10 days

    Duration of the common cold was assessed by the question "Do you still have a cold?" at the end of each treatment day. The duration of the cold was defined as ended by the first day of a "No" answer to this daily question.

  5. Patient Overall Assessment of Efficacy

    Time frame: Day 10

    Patient overall assessment of efficacy was assessed by the question "How effective was the treatment in relieving your common cold symptoms?" at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 17, 2013
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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